Label: MINERAL BLEMISH KIT- sulfur powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 19, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient:

    SULFUR (3%)

  • PURPOSE

    Purpose:

    ACNE TREATMENT

  • INDICATIONS & USAGE

    Uses:

    • FOR TREATMENT OF ACNE
    • HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES AND ALLOWS SKIN TO HEAL
  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When Using This Product

    • USING OTHER TROPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.
  • ASK DOCTOR

    Stop use and ask a doctor if

    • rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    Directions:

    • TAKE THE CONCEALER BRUSH AND DAB INTO THE POWDER. APPLY FORMULA ON AREAS THAT NEED SPOT TREATMENT. USE NIGHTLY TO TREAT AND PREVENT FUTURE BREAKOUTS. AVOID WOUNDS OR ON AREAS OF ECZEMA.
  • INACTIVE INGREDIENT

    Inactive Ingredient:

    MICA, BISMUTH OXYCHLORIDE, ALUMINUM STARCH OCTENYLSUCCINATE, PARAFFINIUM LIQUIDUM (MINERAL OIL), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, SODIUM DEHYDROACETATE. MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    Mineral Blemish Kit

  • INGREDIENTS AND APPEARANCE
    MINERAL BLEMISH KIT 
    sulfur powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-205-213.3 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/10/2013
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Registrant - J. A. Cosmetics U.S. INC (186705047)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture(76354-205)
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